FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLS CHIN PLATE SYSTEM
K Number: K943348
·
Decision Oct 4, 1994
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
6
Review Days
84
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Basic Information
- Device Name
- KLS CHIN PLATE SYSTEM
- K Number
- K943348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Patton, Boggs & Blow
- Date Received
- July 12, 1994
- Decision Date
- October 4, 1994
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Patton, Boggs & Blow
| K Number | Device Name | ||
|---|---|---|---|
| K943346 | MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K943347 | KLS MINI OSTEOSYNTHESIS SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K943345 | MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM | Oct 4, 1994 | Substantially Equivalent |
| K821799 | FITKIT I CHECKUP KIT | Aug 16, 1983 | Substantially Equivalent |
| K823825 | NOSITE UV INTERIM SPECTACLES | Feb 24, 1983 | Substantially Equivalent |